1. Field of the Invention
The invention relates to a medical apparatus, and more specifically to treatment apparatus used in connection with pacemaker implantations.
2. Description of the Prior Art
Subcutaneous pacemaker implants are common throughout the world and many thousands occur each year in the United States alone. The procedure has been simplified such that in many instances the operation is carried out in the physician's office. Under current practice, after the pacemaker is implanted subcutaneously through an incision against the chest wall, the incision is then sutured and a gauze bandage is taped over the implant site to protect and keep the incision site sterile during the healing process. Typically, any swelling or hematoma, which is caused by the trauma of implantation, is left untreated and healing is left to normal body processes. However, in some patients, this trauma is pronounced and very uncomfortable. In extreme cases, the trauma can lead to complications.
Trauma and swelling of the cardiac pacemaker incision site can be substantially reduced and pain alleviated, if in the hours immediately after implantation, a cold compress is applied and maintained on the site. Conventional cold compresses are often used for this purpose and are effective.
However, to obtain the benefit of the cold compress, the compress must be maintained on the site for several hours, typically up to four hours, which is also typically the time of effective cooling of presently available compresses. Also just as typical, the patient desires to be or is mobile and participates in normal ambulatory activity. While it is always possible to tape the compress to the patient's chest, the removal of the tape may be painful and in almost all cases, causes some irritation and in some patients, severe allergic reaction.
A typical cold compress as is currently available, is sold by Health Corps of Cambridge, Mass. under the brand name Omni Pack. The Omni Pack is simply a strip of woven stretch material with Velcro in fasteners on which a terry cloth pouch has been stitched in the center. The terry cloth pouch provides a rectangular space to hold cold or hot packs while the linear strap of the Omni Pack is wrapped around an arm or leg. The Omni Pack is particularly difficult to apply to a patient and to a cardiac implanation site, which is typically on the front chest wall a few inches above the pectoral muscle. The bandage-type attachment on the Omni Pack, even if extended to encircle the chest, simply slips from position.
Other devices used to hold cold packs includes those such as shown by Meistrell, "Adjustable Wrappable, Stretchable Wrap Sheet," U.S. Pat. No. 4,805,620 (1989), which is a wrapping to hold multiple hot or cold packs adjacent to the chest and arm of the body. Meistrell's device substantially covers the entire neck and shoulder area on one side and wraps across the chest with two chest straps as well as anchoring on the upper arm adjacent the covered shoulder. While this device would be effective for holding a compress in the general area of the implant, it is a severely encumbering device, restricting the comfort and motion of the patient.
Lebold, "Hot and Cold Pack," U.S. Pat. No. 3,889,684 (1975) is more typical of the prior art cold packs. It is comprised simply of a terry cloth pouch into which a cold pack is inserted. The terry cloth pouch has a plurality of Velcro straps and fasteners on its periphery which allow it to be strapped around the user's ankle, neck or limbs. The device, however, is particularly ill adapted for fitting to a large irregular body section, the upper chest-shoulder region, which is required for pacer implant treatment.
Bonner, Jr., "Cold Compress," U.S. Pat. No. 4,556,055 (1985) is another typical prior art example of a device for practicing cryotherapy. Bonner, like Lebold, includes a pocket for insertion of the cold pack and a longitudinal panel connected by Velcro fasteners for wrapping the cold pack around a cylindrically shaped body section or limb. Draping the cold pack in the form of Bonner, like a bandolier, across the shoulder and chest of a patient having a pacemaker implant, is neither comfortable, practical nor effective to securely retain the cold pack over the incision site.
What is needed then is some type of device wherein cryotherapy can be practically and comfortably practiced in connection with cardiac pacemaker implants.